Consulting Wallah › Device Explorer › Dental › Dental impression tray, reusable
Device Explorer · FDA GUDID · GMDN 35850

Dental impression tray, reusable

A horseshoe-shaped receptacle made of metal or plastic designed to carry dental impression material to the mouth, to confine the material in opposition to the surfaces to be recorded (e.g., teeth and gums), and to control the impression material while it sets

US‑registered devices982in commercial distribution
Companies36labelers on GUDID
Single‑use11%of device records
Sterile0%labelled sterile
Prescription58%Rx‑only share
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Share of device records

Gc America Inc.34135%
Devemed Gmbh9410%
Power Dental U.S.A. Inc.667%
Osung Mnd Co., Ltd.566%
Ydm Corporation424%
Cowellmedi Co.,Ltd364%
Hager Worldwide, Inc.343%
Tp Orthodontics Inc343%

Top labelers

CompanyDevicesShare
Gc America Inc.34135%
Devemed Gmbh9410%
Power Dental U.S.A. Inc.667%
Osung Mnd Co., Ltd.566%
Ydm Corporation424%
Cowellmedi Co.,Ltd364%
Hager Worldwide, Inc.343%
Tp Orthodontics Inc343%
Scott'S Dental Supply L.L.C.323%
Benco Dental Supply Co.313%
Storz Am Mark Gmbh263%
Sklar Corporation242%

Company = labeler of record on GUDID. 36 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Centric TrayPanthera D-Guide Double sidedPanthera D-Guide Single sidedBorder-Lock® Autoclavable Upper Tray #48RBorder-Lock® Autoclavable Upper Tray #46RBorder-Lock® Autoclavable Lower Tray #58Border-Lock® Autoclavable Lower Tray #57Border-Lock® Autoclavable Lower Tray #56Border-Lock® Autoclavable Lower Tray #55Border-Lock® Autoclavable Lower Tray #54Border-Lock® Autoclavable Lower Tray #53Border-Lock® Autoclavable Lower Tray #52Border-Lock® Autoclavable Lower Tray #51Border-Lock® Autoclavable Upper Tray #49Border-Lock® Autoclavable Upper Tray #48LBorder-Lock® Autoclavable Upper Tray #47

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
EBHMATERIAL, IMPRESSION TRAY, RESIN408
EHYTray, Impression, Preformed273
EHYTRAY, IMPRESSION, PREFORMED262
NDPAccessories, Implant, Dental, Endosseous38
EBHMaterial, Impression Tray, Resin22
DZNINSTRUMENTS, DENTAL HAND20

GMDN & GCC registration

  • GMDN code 35850 · non‑implantable
  • Single‑use 11% · sterile 0% · Rx‑only 58% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

Use these as the dimensions to specify in a tender line.

How many dental impression tray, reusable products are registered in the US?

982 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental impression tray, reusable", from 36 companies. The largest labeler is Gc America Inc. with 35% of records.

Which FDA product codes apply?

EBH (MATERIAL, IMPRESSION TRAY, RESIN), EHY (Tray, Impression, Preformed), EHY (TRAY, IMPRESSION, PREFORMED), NDP (Accessories, Implant, Dental, Endosseous)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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